Molecular Imaging of Active Venous Thrombus With Positron Emission Tomography (PET) (THROMPET)
Primary Purpose
Venous Thromboembolism (VTE)
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Additional blood sampling
Sponsored by
About this trial
This is an interventional basic science trial for Venous Thromboembolism (VTE)
Eligibility Criteria
Inclusion Criteria: Major patient (≥18 years), voluntary blood donor, with no notable medical history altering coagulation (i.e. known thrombophilia, active cancer), no chronic pathology, no current treatment. Exclusion Criteria: Minor patient (<18 years); known chronic pathology; long-term treatment including anti-platelet aggregation therapy or anticoagulant treatment, refusal to participate.
Sites / Locations
Outcomes
Primary Outcome Measures
Evaluation of the affinity and specificity of binding of a positron emitter-labeled anti-Dimer antibody (64Copper) to fresh blood thrombus in vitro.
Evaluation of the binding rate of a 64Copper-labeled D-dimer-specific monoclonal antibody (64Cu-Antibody) on fresh blood thrombus from healthy donors. The rate of binding will be assessed by measuring the radioactivity present on the thrombus (64Cu-Antibody bound to the thrombus) and the radioactivity present in the supernatant (64Cu-Antibody not bound to the thrombus).
Secondary Outcome Measures
Optimize the antibody concentration required for the most effective tracer binding (64Cu-Antibody) to the thrombus.
Determination of the optimum 64Cu-Antibody concentration for the most effective thrombus labeling. Incorporate increasing amounts of 64Cu Antibody concentration, and measure the amount of binding to fresh thrombus and to the supernatant.
Full Information
NCT ID
NCT06057844
First Posted
September 19, 2023
Last Updated
September 26, 2023
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT06057844
Brief Title
Molecular Imaging of Active Venous Thrombus With Positron Emission Tomography (PET)
Acronym
THROMPET
Official Title
Molecular Imaging of Active Venous Thrombus With Positron Emission Tomography (PET)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and/or pulmonary embolism (PE), is a major public health issue. VTE is the third most common acute cardiovascular pathology, after myocardial infarction and stroke.
Diagnostic accuracy is essential in the case of VTE, in order to select patients for whom anticoagulant treatment is necessary, and to avoid long-term treatment of patients who will derive no benefit from it.
The management of patients with suspected PE is based on diagnostic strategies that use either ventilation-perfusion planar lung scintigraphy or thoracic angioscanner imaging as the cornerstone. These 2 techniques correspond to what might be termed "negative" imaging, i.e. visualization of the vascular repercussions downstream of an obstruction, whatever its nature.
A research prospect in the field of VTE diagnosis is the direct marking of the various elements of the active venous thrombus, which could correspond to "positive" thrombus imaging.
Numerous studies have already investigated the role of molecular imaging in the diagnosis of VTE, especially in the diagnosis of DVT. However, these studies used conventional scintigraphy to evaluate these tracers, a technique lacking in sensitivity and with insufficient spatial resolution.
Nuclear medicine and molecular imaging have undergone a technological revolution since the early 2000s, with the development of positron emission tomography (PET). The technical advantages of PET over conventional scintigraphy include greater sensitivity and higher spatial resolution (4 mm for PET vs. 12 mm for conventional scintigraphy), which may have been the limiting factor in studies already carried out.
The aim of this project is to develop a new radiopharmaceutical for use in PET scans, a biomarker of active venous thrombus, with a view to improving the diagnosis of MVTE and hence patient management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism (VTE)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Additional blood sampling
Intervention Description
Once you have been informed and have given your consent, 2 tubes of venous blood (citrated tubes of approximately 5 milliliters (ml) each) will be taken after the blood donation to enable in vitro thrombus formation. The entire sample will be used, and no surplus will be kept in the bank.
Primary Outcome Measure Information:
Title
Evaluation of the affinity and specificity of binding of a positron emitter-labeled anti-Dimer antibody (64Copper) to fresh blood thrombus in vitro.
Description
Evaluation of the binding rate of a 64Copper-labeled D-dimer-specific monoclonal antibody (64Cu-Antibody) on fresh blood thrombus from healthy donors. The rate of binding will be assessed by measuring the radioactivity present on the thrombus (64Cu-Antibody bound to the thrombus) and the radioactivity present in the supernatant (64Cu-Antibody not bound to the thrombus).
Time Frame
Day +0
Secondary Outcome Measure Information:
Title
Optimize the antibody concentration required for the most effective tracer binding (64Cu-Antibody) to the thrombus.
Description
Determination of the optimum 64Cu-Antibody concentration for the most effective thrombus labeling. Incorporate increasing amounts of 64Cu Antibody concentration, and measure the amount of binding to fresh thrombus and to the supernatant.
Time Frame
Day +0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Major patient (≥18 years), voluntary blood donor, with no notable medical history altering coagulation (i.e. known thrombophilia, active cancer), no chronic pathology, no current treatment.
Exclusion Criteria:
Minor patient (<18 years); known chronic pathology; long-term treatment including anti-platelet aggregation therapy or anticoagulant treatment, refusal to participate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe ROBIN
Phone
+33(0)298223327
Email
philippe.robin@chu-brest.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Molecular Imaging of Active Venous Thrombus With Positron Emission Tomography (PET)
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